Radiation before mastectomy with immediate breast reconstruction

Preoperative Radiation Therapy and Immediate Breast Reconstruction, a Phase 3 Randomized Controlled Trial in the Belgian Population

This trial tests whether giving radiation before mastectomy combined with immediate breast reconstruction improves cosmetic results and quality of life for women who need mastectomy and post‑mastectomy radiation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Cancer Research Antwerp (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 6 sites (Edegem, Antwerpen and 5 other locations)
• Trial ID: NCT06739655 on ClinicalTrials.gov

What this trial studies

PRADAIIBE is a multicenter, randomized phase III trial enrolling adult women in Belgium who require mastectomy and post‑mastectomy radiation and who want breast reconstruction. After consent and baseline questionnaires and photographs, participants are randomized to either standard care (mastectomy, postoperative radiation, and delayed or immediate reconstruction) or experimental care (preoperative radiation followed by immediate reconstruction). The primary endpoint is breast satisfaction at one year measured by the BREAST‑Q, with secondary endpoints including quality of life scores, aesthetic panel scores, treatment duration, pathological complete response, adverse events, and survival. Centralized randomization and standardized outcome instruments are used to ensure comparability across sites.

Who should consider this trial

Good fit: Adult women (≥18 years) with histologically confirmed breast cancer who require mastectomy and chest wall/post‑mastectomy radiation, desire breast reconstruction, and have ECOG performance status 0–2 are ideal candidates.

Not a fit: Patients with prior chest irradiation, a history of prior breast cancer, those who do not require post‑mastectomy radiation, or those medically unfit for reconstruction are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could improve cosmetic outcomes and quality of life while potentially shortening overall treatment time for women needing mastectomy and radiation.

How similar studies have performed: Small observational studies and early-phase reports have suggested feasibility and acceptable complication rates for preoperative radiation with immediate reconstruction, but definitive phase III evidence is limited.

Eligibility criteria

Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation.

Inclusion criteria:

In order to be eligible to participate in this study, a participant must meet all of the following criteria:

1\. Women ≥18 years with histopathologically confirmed breast cancer who:

1.a. require SSM/NSM for any reason (e.g. extensive disease)

1.b. require postoperative radiation therapy of at least the chest wall

1. c. have a wish for a breast reconstruction
2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol.

Exclusion criteria:

A potential participant who meets any of the following criteria will be excluded from participation in this study:

1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic SSM/NSM), or previous contralateral breast cancer disease/treatment, do not fall under this criterium and are thus allowed.
2. Collagen synthesis disease
3. Ongoing pregnancy
4. Actively breastfeeding
5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \>3months preoperatively.
6. BMI \> 35 kg/m2
7. cT4d tumour, metastatic disease or any reason making SSM/NSM not indicated

Where this trial is running

Edegem, Antwerpen and 5 other locations

• Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Antwerpen, Belgium (Recruiting)
• Ziekenhuis aan de stroom — Wilrijk, Antwerpen, Belgium (Recruiting)
• AZ Klina — Brasschaat, Antwerp, Belgium (Not_yet_recruiting)
• CHU Namur — Namur, Namur, Belgium (Recruiting)
• Universitair Ziekenhuis Gent (UZGent) — Ghent, Oost Vlaanderen, Belgium (Not_yet_recruiting)
• AZ Groeninge — Kortrijk, West Vlaanderen, Belgium (Recruiting)

Study contacts

• Principal investigator: Melanie Machiels, MD, PhD — Iridium netwerk
• Study coordinator: Tom Quisenaerts, MD

Conditions Breast Neoplasms; Breast Carcinoma; Breast Adenocarcinoma; Cancer; Neoplasm; Breast cancer; Radiotherapy; PRADA